Leaflet:information for the patient

Valsaros 10mg/80mg film-coated tablets

Valsaros 20mg/80mg film-coated tablets

Valsaros 10mg/160mg film-coated tablets

Valsaros 20mg/160mg film-coated tablets

rosuvastatina/valsartán

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Valsaros and for what it is used

2.What you need to know before starting to take Valsaros

3.How to take Valsaros

4.Possible side effects

5.Storage of Valsaros

6.Contents of thepackaging and additional information

Valsaros contains two active ingredients: rosuvastatina and valsartán.

Valsaros is indicated for the treatment of high blood pressure that occurs with high levels of cholesterol and/or for the prevention of cardiovascular events.

Do not take Valsaros:

• If you are allergic to valsartan, rosuvastatin, or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding. If you become pregnant during treatment with Valsaros, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Valsaros by using appropriate contraceptive methods.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral liver infection called hepatitis C).
• If you are taking a medication called ciclosporina (used, for example, after organ transplants).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskireno.

If you are affected by any of the situations mentioned above (or have doubts),refer to your doctor again..

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valsaros.

• If you have kidney problems or are undergoing dialysis.
• If you have liver problems.
• If you have repeated or unexplained muscle pain or cramps, a personal or family history of muscle problems, or a history of muscle problems during treatment with other medications to lower cholesterol levels. Inform your doctor immediately if you have unexplained muscle pain, especially if you feel unwell or have a fever.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you are taking other medications to lower cholesterol called fibrates. Please read this leaflet carefully even if you have taken other medications to treat high cholesterol levels before.
• If you are taking medications to treat HIV, for example: ritonavir with lopinavir and/or atazanavir; see section "Taking Valsaros with other medications".
• If you are over 70 years old (since your doctor must choose the starting dose of Valsaros that is most suitable for you).
• If you have severe respiratory failure.
• If you are of Asian origin: Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian, for example, since your doctor must choose the starting dose of Valsaros that is most suitable for you.
• If you have a narrowing of the renal artery.
• If you have recently undergone a kidney transplant (you have received a new kidney).
• If you are being treated for a heart attack or heart failure; your doctor may check your renal function.
• If you have a severe heart disease other than heart failure or heart attack.
• If you have ever experienced swelling of the tongue and face due to an allergic reaction — angioedema — while being treated with other medications (including ACE inhibitors). If you experience these symptoms during treatment with Valsaros, stop it immediately and do not take it again. See section 4 "Possible side effects".
• If you are taking medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin. You may need to have your potassium levels in the blood checked regularly.
• If you have aldosteronism: a disease in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Valsaros is not recommended.
• If you have lost a lot of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics.
• If you are taking any of the following medications used to treat high blood pressure:
• An ACE inhibitor (for example: enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskireno.
• If you are being treated at the same time with an ACE inhibitor and other medications specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example: spironolactone, eplerenone) or beta-blockers (for example: metoprolol).
• If you are taking or have taken within the last 7 days a medication called fusidic acid (a medication for bacterial infections) by mouth or injection. The combination of fusidic acid and Valsaros may cause severe muscle problems (rhabdomyolysis).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking rosuvastatin or other related medications.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), since statins can sometimes worsen the disease or cause myasthenia (see section 4).

In a small number of people, statins can affect the liver. This is detected by a simple test that detects increased levels of liver enzymes (transaminases) in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and after treatment with Valsaros.

If you have diabetes or are at risk of developing it, your doctor will closely monitor you while you are taking this medication. You are likely to be at risk of developing diabetes if you have high sugar and fat levels in the blood, obesity, and high blood pressure.

Your doctor may check your renal function, blood pressure, and electrolyte levels (such as potassium) in the blood at regular intervals.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported associated with rosuvastatin treatment. Stop using rosuvastatin and seek medical attention immediately if you notice any of the symptoms described in section 4.

See also the information under the heading "Do not take Valsaros".

If any of the above situations affect you, inform your doctor before taking Valsaros.

Taking Valsaros with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you are taking any of the following medications:

• Ciclosporina (used, for example, after organ transplants).
• Anticoagulants, for example: Warfarin, acenocoumarol, or fluindione (the anticoagulant effect and the risk of bleeding may increase if taken with this medication), ticagrelor, or clopidogrel.
• Fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimiba).
• Medications for indigestion (used to neutralize stomach acid).
• Erythromycin (an antibiotic).
• Oral contraceptives (birth control pill).
• Hormone replacement therapy.
• Other medications used to treat high blood pressure, especially diuretics.
• Medications that increase the amount of potassium in the blood. These include potassium supplements or salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Some antibiotics (belonging to the rifampicin group), a medication used to prevent organ rejection after a transplant (ciclosporina), or an antiretroviral medication used to treat HIV/AIDS (ritonavir with lopinavir and/or atazanavir). These medications increase the effect of Valsaros.
• Lithium, a medication used to treat certain types of psychiatric diseases.
• If you are taking an ACE inhibitor or aliskireno (see also the information under the headings "Do not take Valsaros" and "Warnings and precautions").
• If you are being treated at the same time with an ACE inhibitor and other medications specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example: spironolactone, eplerenone) or beta-blockers (for example: metoprolol).
• If you need to take fusidic acid by mouth to treat a bacterial infection, you should temporarily stop taking this medication. Your doctor will indicate when it is safe to resume treatment with Valsaros. The combination of Valsaros and fusidic acid may rarely cause muscle weakness, palpitations, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Regorafenib (used to treat cancer).
• Darolutamida (used to treat cancer).
• Any of the following medications used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and Precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.

The effects of these medications may be modified by Valsaros or change the effect of Valsaros.

Taking Valsaros with food and drinks

You can take Valsaros with or without food.

Pregnancy and breastfeeding

Do not take Valsarosif you are pregnant or breastfeeding. If you become pregnant during treatment with Valsaros,stop taking it immediatelyand inform your doctor. Women should avoid becoming pregnant during treatment with Valsaros by using appropriate contraceptive methods. Ask your doctor or pharmacist for advice before starting treatment with this medication.

• You must inform your doctor if you think you are (or may become) pregnant.Your doctor will usually tell you to stop taking Valsaros before becoming pregnant or as soon as you become aware of your pregnancy, and will prescribe another treatment different from Valsaros.

• Inform your doctor if you are breastfeeding or plan to start.No treatment with Valsaros is recommended for women who are breastfeeding. Your doctor must choose another treatment if you want to breastfeed.

Driving and operating machines

Before driving a vehicle, using tools, or operating machines, or performing any other activity that requires concentration, make sure you know how Valsaros affects you. Like many other medications used to treat high blood pressure, Valsaros may cause, in rare cases, dizziness and affect concentration. If you feel dizzy, consult your doctor before driving or operating machines.

Valsaros contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per dose, that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Usual doses in adults

The recommended dose is one tablet per day.

You can take your medication before or after meals and drinks. Take this medication every day at the same time with water. Do not take this medication with grapefruit juice.

Use in children and adolescents

Valsaros should not be used in children or adolescents.

Regular cholesterol level checks

It is essential that you attend your doctor regularly for cholesterol checks to verify that your cholesterol levels have normalized and are maintained at appropriate levels.

Your doctor may decide to increase your dose so that you take the appropriate amount of Valsaros for you.

If you take more Valsaros than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you experience severe dizziness and/or fainting, lie down. If you visit the hospital or receive treatment for another condition, inform the healthcare staff that you are taking Valsaros.

If you forget to take Valsaros

Do not worry. Simply take the next scheduled dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Valsaros

Consult your doctor if you want to interrupt treatment with Valsaros. Stopping treatment with Valsaros may worsen your condition. Your cholesterol levels may increase again if you stop taking Valsaros. Do not stop taking this medication unless your doctor tells you to.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

It is important that you know which side effects may occur. They are usually mild and disappear within a short period of time.

Stop taking Valsaros and seek medical attention immediatelyif you experience any of the following side effects:

• Difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat.
• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Intense skin itching (with rashes).
• Blisters on the skin, mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
• Syndrome similar to lupus (including rash, joint disorders, and effects on blood cells).
• Muscle rupture.
• Reddish patches on the trunk, often with blisters, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

If you experience any of the above symptoms, stop taking Valsaros and consult a doctor immediately (see also section 2 "Warnings and precautions").

Also, stop taking Valsaros and consult your doctor immediately if you experience unexplained muscle pain and crampsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. Like other statins, a very small number of people have experienced unpleasant muscle side effects, which, very rarely, have resulted in a potentially fatal muscle injury calledrabdomiólisis.

Common side effects(may affect up to 1 in 10 people):

• Dizziness.
• Low blood pressure with or without symptoms such as dizziness or fainting when standing up.
• Decreased kidney function (signs of kidney insufficiency).
• Headache.
• Abdominal pain.
• Constipation.
• Nausea.
• Muscle pain.
• Weakness.
• Diabetes. This is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Rare side effects(may affect up to 1 in 100 people):

• Angioedema (see the section "Stop taking Valsaros and seek medical attention immediately").
• Sudden loss of consciousness (syncope).
• Sensation of rotation (vertigo).
• Marked reduction in kidney function (signs of acute kidney insufficiency).
• Muscle spasms, abnormal heart rhythm (signs of hypokalemia).
• Shortness of breath, difficulty breathing while lying down, swelling of the feet or legs (signs of heart failure).
• Cough.
• Diarrhea.
• Fatigue.
• Weakness.
• Skin rash, itching, or other skin reactions.
• Increased protein in urine —usually returns to normal without the need to discontinue treatment with Valsaros tablets—.

Very rare side effects(may affect up to 1 in 10,000 people):

• Severe allergic reaction. Symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing, and/or intense skin itching (with rashes).If you think you are having an allergic reaction, stop taking Valsarosand seek medical attention immediately.
• Muscle injury in adults. As a precaution,stop taking Valsaros and consult a doctor immediately if you experience unexplained muscle pain or crampsthat last longer than expected.
• Intense stomach pain (possible sign of pancreatitis).
• Increased liver enzymes in the blood.
• Reduced platelet count, increasing the risk of bleeding or bruising (thrombocytopenia).

Very rare side effects(may affect up to 1 in 10,000 people):

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflammation of the liver).
• Traces of blood in urine.
• Nerve damage in legs and arms (such as numbness or tingling).
• Joint pain.
• Memory loss.
• Gynecomastia (enlargement of breast tissue in men).

Side effects of unknown frequency(frequency cannot be estimated from available data):

• May occur allergic reactions with rash, itching, and urticaria, fever symptoms, joint inflammation, and joint pain, muscle pain, lymph node swelling, and/or flu-like symptoms (signs of serum disease).
• Reddish purpuric patches, fever, itching (signs of blood vessel inflammation, also known as vasculitis).
• Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count, also known as neutropenia).
• Reduced hemoglobin levels and reduced percentage of red blood cells in the blood (which can cause anemia in severe cases).
• Increased potassium levels in the blood (which, in severe cases, can cause muscle spasms and abnormal heart rhythm).
• Reduced sodium levels in the blood (which can cause fatigue, confusion, muscle twitching, seizures, or coma).
• Elevated liver function values (which can indicate liver damage), including increased bilirubin levels in the blood (which, in severe cases, can cause yellowing of the skin and eyes).
• Increased levels of urea nitrogen in the blood and increased serum creatinine levels (which can indicate renal anomalies).
• Shortness of breath.
• Edema (swelling).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon damage.
• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness, which, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

The frequency of some side effects may vary depending on your condition. For example: certain side effects such as dizziness and reduced kidney function were observed less frequently in patients treated for hypertension than in patients treated for heart failure or after a recent heart attack.

If any of the side effects you experience are severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Do not dispose of medications through drains or trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Valsaros

The active principles are rosuvastatina and valsartán.

Valsaros 10mg/80mg film-coated tablets

Each tablet contains 10mg of rosuvastatina (as calcium salt) and 80mg of valsartán.

Valsaros 20mg/80mg film-coated tablets

Each tablet contains 20mg of rosuvastatina (as calcium salt) and 80mg of valsartán.

Valsaros 10mg/160mg film-coated tablets

Each tablet contains 10mg of rosuvastatina (as calcium salt) and 160mg of valsartán.

Valsaros 20mg/160mg film-coated tablets

Each tablet contains 20mg of rosuvastatina (as calcium salt) and 160mg of valsartán.

The other components are:

Core tablet:microcrystalline cellulose (E460i), lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate (E470b), mannitol (E421), polividone K25, sodium lauryl sulfate and yellow iron oxide (E172)

Coating:polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, red iron oxide (E172) —only for Valsaros 10mg/80mg, 20mg/80mg and 10mg/160mg film-coated tablets— and yellow iron oxide (E172) —only for Valsaros 10mg/160mg and 20mg/160mg film-coated tablets.

See section 2 “Valsaros contains lactose” and sodium.

Appearance of the product and contents of the pack

Valsaros 10mg/80mg film-coated tablets

Dark red film-coated, round, slightly biconvex tablets with beveled edges and engraved with the mark “K4” on one face.

Diameter: 8.7–9.3mm.

Valsaros 20mg/80mg film-coated tablets

Dark red film-coated, capsule-shaped, slightly biconvex tablets engraved with the mark “K3” on one face.

Dimensions: 14.7–15.3mm×6.7–7.3mm.

Valsaros 10mg/160mg film-coated tablets

Dark red film-coated, oval, biconvex tablets engraved with the mark “K2” on one face.

Dimensions: 16.7–17.3mm×7.7–8.3mm.

Valsaros 20mg/160mg film-coated tablets

Yellow-brown film-coated, oval, biconvex tablets engraved with the mark “K1” on one face.

Dimensions: 16.7–17.3mm×7.7–8.3mm.

Valsaros is available in blisters contained in cartons with 10, 14, 20, 28, 30, 56, 60, 84, 90 or 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Further information can be obtained by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura, 10, Pta. Baja, Oficina 1, 28108Alcobendas, Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Last revision date of this leaflet:May 2023

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).